The hearing gath­ered input on spe­cific issues and chal­lenges asso­ci­ated with the imple­men­ta­tion of the Bio­logics Price Com­pe­ti­tion and Inno­va­tion Act of 2009. The act was cre­ated to estab­lish an approval pathway for bio­log­ical prod­ucts that are “highly sim­ilar” (biosim­ilar) to FDA-​​licensed bio­log­ical drugs.

In March, North­eastern and the FDA signed a mem­o­randum of under­standing to advance methods of analysis for devel­oping biosim­i­lars. The agree­ment estab­lished a research col­lab­o­ra­tion, along with edu­ca­tional, training and out­reach pro­grams for mem­bers of the FDA, industry and acad­emia in the areas of biotech­nology and ana­lyt­ical chemistry.

Northeastern’s Center for Advanced Reg­u­la­tory Analysis, housed within the Bar­nett Insti­tute of Chem­ical and Bio­log­ical Analysis, is leading sev­eral research projects, including the devel­op­ment of methods to assess the struc­tural attrib­utes, safety and effi­cacy of bio­log­ical drugs.

“The hearing pro­vided an ideal venue to show­case the power of ana­lyt­ical tech­nology in resolving issues sur­rounding bioe­quiv­a­lence of branded and soon-to–be-introduced generic bio­phar­ma­ceu­ti­cals,” said Jones. “Our Bar­nett Insti­tute has pio­neered the appli­ca­tion of these methods for a number of decades, and it was grat­i­fying to note the high level of interest in the tes­ti­mony both from the reg­u­la­tors and bio­phar­ma­ceu­tical industry.”

Sharing the podium with part­ners from Waters Corp., Jones noted that they were able to high­light cutting-​​edge advances by a number of North­eastern lab­o­ra­to­ries and researchers, including those of Bar­nett Insti­tute director Barry Karger and asso­ciate pro­fes­sors of chem­istry and chem­ical biology John Engen and Sunny Zhou.

“Given that health is one of the three great research chal­lenges that North­eastern focuses on,” said Jones, “it is note­worthy that, through this hearing, we will have played a role in the for­ma­tion of policy sur­rounding intro­duc­tion of the new classes of bio­phar­ma­ceu­ti­cals — the fastest growing seg­ment of the $600 bil­lion phar­ma­ceu­tical industry.”

The hearing was a forum for researchers, doc­tors, drug com­pa­nies and phar­macy groups to pro­vide input on FDA imple­men­ta­tion of the statute.

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